FDA seeks more study of diabetes drug heart risk
Wed Dec 17, 2008 5:08pm EST
By Lisa Richwine
WASHINGTON, Dec 17 (Reuters) - Drug companies need to more thoroughly study potential heart-related risks of new diabetes medicines before they reach the market, U.S. health officials said on Wednesday.
The decision will mean longer, larger and more expensive studies for many drugmakers seeking to sell new therapies in a $6 billion U.S. market that was hit by safety concerns with GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research, Stock Buzz) diabetes pill, Avandia.
Companies must "ensure that a new therapy does not increase cardiovascular risk to an unacceptable extent," the Food and Drug Administration said in new guidelines.
Glaxo, Bristol-Myers Squibb Co (BMY.N: Quote, Profile, Research, Stock Buzz), AstraZeneca Plc (AZN.L: Quote, Profile, Research, Stock Buzz), Eli Lilly and Co (LLY.N: Quote, Profile, Research, Stock Buzz), Amylin Pharmaceutical Inc (AMLN.O: Quote, Profile, Research, Stock Buzz) and Novo Nordisk (NOVOb.CO: Quote, Profile, Research, Stock Buzz) are among the companies trying to bring new diabetes drugs to the market.
The new standards apply immediately to all diabetes drugs in development, and drugmakers have been notified, the FDA said.
Until now, companies generally needed to show only that their diabetes medicines lowered blood sugar.
The FDA, however, has grown concerned about heart attacks and other cardiovascular risks from medicines taken long-term to treat chronic conditions.
Nearly 24 million Americans have diabetes, the U.S. government estimates. Most cases are type 2 diabetes, which is linked with obesity, poor diet and lack of exercise.
Experts agree blood sugar control helps prevent diabetes complications such as eye and kidney damage. No conclusive evidence shows any diabetes drug reduces heart disease, the top killer of diabetics, the FDA said.
The new FDA recommendations urge companies to show a diabetes drug does not increase chances of cardiovascular harm when compared with existing treatments. Companies must include more patients with a higher risk of heart complications such as the elderly and people with kidney damage, said Dr. Mary Parks, head of the FDA division that reviews diabetes drugs.
Late-stage studies that now last about six months could take a year to gather the needed data, Parks told reporters.
Concern that diabetes medicines may damage the heart arose last year when Cleveland Clinic researchers found Glaxo's pill Avandia increased the chances of a heart attack.
Dr. Steven Nissen, lead author of the Avandia study, said the FDA guidelines largely reflected a proposal he made in July to an advisory panel urging more safety data before approval with additional study once a drug reaches the market.
"It's setting the bar at an appropriate level that will give us the information we need to make good treatment decisions," Nissen, a cardiologist, said in an interview.
Glaxo has said Avandia's safety is comparable to similar pills. The company agreed to add a strong warning that the drug might increase heart attack risk with a note that the data was inconclusive. Studies of its heart effects are continuing.
The FDA said it was developing other heart risk guidelines for diabetes drugs already on the market. (Reporting by Lisa Richwine; Editing by Lisa Von Ahn and Tim Dobbyn) |
